DHF, DMR, DHR Process, Part 4
Device History Records, DHF, DHR, DMR, QSR, Quality Assurance
This is the 4thof the 4-part series around tips for leveraging the interrelationship between the Design History File (DHF), Device Master Record (DMR) and Device History Records (DHR’s). This tip is focused on creating Device History Records (DHR’s) based on the DMR.
In the previous Device Tip on this subject, we know that the Device Master Record (DMR) comprises:
- Device specifications including appropriate drawings, composition, formulation, component specifications, and software specifications;
- Production process specifications including the appropriate equipment specifications, production methods, production procedures, and production environment specifications;
- Quality assurance procedures and specifications including acceptance criteria and the quality assurance equipment to be used;
- Packaging and labeling specifications, including methods and processes used; and
- Installation, maintenance, and servicing procedures and methods.
And we know from another prior Device Tip that Device History Records (DHR’s) provide a compilation of records containing the production history of a finished device. Actual Device History Record is a bit of a misnomer since the QSR says “Each manufacturer shall establish and maintain procedures to ensure that DHR’s for each batch, lot, or unit are maintained to demonstrate that the device is manufactured in accordance with the DMR…” So a DHR can be for a unit, lot or batch.
So since the DHR needs to demonstrate that the device is manufactured in accordance with the DMR, here’s the next tip:
Create a DHR Form for each product with places to record, reference and/or attach all the required elements for that product.
These “required” elements are those that demonstrate that the unit, lot or batch was manufactured in accordance with the DMR.
More Info
The QSR specifies that the minimum information to be recorded in the DHR is:
- The dates of manufacture;
- The quantity manufactured;
- The quantity released for distribution;
- The acceptance recordswhich demonstrate the device is manufactured in accordance with the DMR;
- The primary identification label and labeling used for each production unit; and
Any device identification(s) and control number(s) used
So to start off, the DHR Form for a specific product would include places to record, reference and/or attach all the above elements for a specific unit, lot or batch.
The dates of manufacture, quantity manufactured and the quantity released for distribution are all straightforward results on the production of each unit, lot or batch.
The acceptance records typically comprise:
- The records specified in the Quality assurance procedures of the DMR, and
- A reference to the Revision level of the Top Assembly for the specific unit, lot or batch
The Revision level of the Top Assembly typically provides a reference to the individual Revision levels of all constituent components, subassemblies, manufacturing procedures and Quality Assurance procedures for the specific unit, lot or batch. This is commonly known as the “configuration” of the device and will be discussed in a future Device Tip in this series. It’s also a good idea for the DHR Form to include places to record, reference and/or attach information to demonstrate that the latest revision of required sub-assembly procedures were used for that unit, lot or batch. The DHR Form would also include places to record, reference and/or attach information to demonstrate that all Quality Assurance activities were performed with acceptable results for that unit, lot or batch.
The primary identification label and labeling are typically included in the configuration of the Top Assembly, and thus can be referred to by the Revision level of the Top Assembly.
The device identification(s) and control number(s) used typically comprise:
- The Serial Number, Lot Number or Batch Number for the Top Assembly produced, and
- The Serial Number(s), Lot Number(s) or Batch Number(s) for any Critical components for the device
Recording the identification and control number(s) of Critical components provides traceability of these Critical components to the specific unit, lot or batch produced. The identification of the Critical components for a device will be discussed in a future Device Tip in this series.